What IDEAYA Biosciences, Inc. told the SEC could break it.

IDEAYA owns no manufacturing or clinical-trial infrastructure and relies on third parties for substantially all of its preclinical studies, clinical trials and manufacturing. Some of the raw materials needed to make its product candidates are available only from limited or sole sources, and as a small company its negotiating leverage is limited, often giving it lower priority than larger competitors for supply. A supply interruption of limited or sole-sourced raw materials could materially harm its ability to manufacture product candidates until an alternative source is identified and qualified — a process that can be lengthy for biologics/ADCs — and CRO/CMO performance failures could delay or prevent regulatory submissions.

“Any supply interruption in limited or sole sourced raw materials could materially harm our ability to manufacture our product candidates until a new source of supply, if any, could be identified and qualified.”

IDEAYA's pipeline includes programs partnered with China-based companies — IDE849, in-licensed/partnered with Hengrui Pharma and being run in a Phase 1 trial in China, and IDE034 in-licensed from Biocytogen. It flags significant uncertainty about global trade relationships, including potential changes to trade laws, trade policies and tariffs, and notes that foreign governments including China have instituted retaliatory tariffs and could impose more (and that products may become subject to U.S. export-control restrictions). Escalating US-China trade and export-control measures could complicate or raise the cost of these cross-border clinical and manufacturing collaborations. Severity is low given its pre-revenue status and the absence of a quantified impact.

“Some foreign governments, including China, have instituted retaliatory tariffs on certain U.S. goods and have indicated a willingness to impose additional tariffs on U.S. products.”